510(k) K133598 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
CARDIOHELP SYSTEM
| Applicant | Maquet Cardiopulmonary, AG, Wayne NJ, US |
| Decision | Substantially Equivalent, May 21, 2014 |
| Received | Nov 22, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133598
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2026 | Maquet Cardiopulmonary Gmbh Bubble Sensor for 3/8" x 3/32" tubing;
Model Number: 701055720; Open, Classified |
DTQ | None listed |
| Sep 30, 2024 | Maquet Medical Systems USA CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for pe Open, Classified |
DTQ | None listed |
| May 16, 2024 | Maquet Medical Systems USA CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system. Open, Classified |
DTQ | None listed |
| Feb 8, 2024 | Maquet Medical Systems USA Bubble Sensor (REF: 70105.5720) Open, Classified |
DTQ | None listed |
| Dec 21, 2023 | Maquet Medical Systems USA Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802 Open, Classified |
DTQ | None listed |
| Dec 14, 2023 | Maquet Medical Systems USA CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for Open, Classified |
DTQ | None listed |
| Dec 7, 2023 | Maquet Medical Systems USA CARDIOHELP Emergency Drive, Part Numbers 701048002 and 701076205. The CARDIOHELP System is a blood oxygenation and carbon dioxide removal system. Open, Classified |
DTQ | None listed |
| Nov 9, 2023 | Maquet Medical Systems USA Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder) Open, Classified |
DTQ | None listed |
| Feb 18, 2022 | Maquet Medical Systems USA Cardiohelp-i Transport Guard with Transport Guard (701072525):
is a blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory a Open, Classified |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.